mrna-20240331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549


FORM			10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _ to _

Commission File Number: 001-38753

Moderna, Inc.

(Exact Name of Registrant as Specified in Its Charter)


Delaware		81-3467528
(State or Other Jurisdiction of Incorporation or Organization)		(IRS Employer Identification No.)

325 Binney Street
Cambridge,	Massachusetts	02142
(Address of Principal Executive Offices)		(Zip Code)

(617) 714-6500

(Registrant’s Telephone Number, Including Area Code)

200 Technology Square, Cambridge, Massachusetts 02139

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0001 per share	MRNA	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☒

Accelerated filer o

Non-accelerated filer o

Smaller reporting company

☐

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of April 26, 2024, there were 383,239,726 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (Form 10-Q) contains express or implied forward-looking statements. All statements other than those of historical facts contained in this Form 10-Q are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements in this Form 10-Q include, but are not limited to, statements about:

•our activities with respect to our COVID-19 vaccine, and our plans and expectations regarding future generations of our COVID-19 vaccine that we may develop, including in response to variants of the SARS-CoV-2 virus, ongoing clinical development, manufacturing and supply, pricing, commercialization, regulatory matters (including authorization or approval for updated vaccines), demand for COVID-19 vaccines, our provisions for product returns, and third-party and governmental arrangements and potential arrangements;

•our expectations regarding the endemic and seasonal commercial market for COVID-19 vaccines and our preparations for and ability to effectively compete in such a market, as well as the impact that the evolving market will have on our financial returns;

•expected sales and delivery of our COVID-19 vaccine in future periods, and expected seasonality for sales;

•mRNA-1283’s design to be refrigerator-stable and its potential for paving the way for a combination vaccine;

•our expectations regarding regulatory approvals for our respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345), and the U.S. ACIP recommendation in 2024, and plans for commercialization of this product;

•our financing arrangement with Blackstone Life Sciences, and other funding options we may consider as part of our research and development strategy;

•our ability to successfully contract with third-party suppliers, distributors and manufacturers;

•our ability and the ability of third parties with whom we contract to successfully manufacture, supply and distribute our COVID-19 vaccine and any future commercial products at scale, as well as drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical and clinical use;

•internal and external costs associated with manufacturing our products, including our COVID-19 vaccine, and the impact on our cost of sales, and our anticipated 2024 cost of sales as a percentage of net product sales;

•the scope of protection we are able to establish and maintain for intellectual property rights covering our commercial products, product candidates and technology, including our ability to enter into license agreements, and our expectations regarding pending legal proceedings related to our intellectual property;

•the potential of our individualized neoantigen therapy (INT) program and our plans for the program, including to expand to additional tumor types;

•the timing of initiation, progress, completion, results and cost of our clinical trials, preclinical studies and research and development programs, as well as those of our collaborators;

•participant enrollment in our clinical trials, including enrollment demographics and timing;

•potential advantages of mRNA as compared to traditional medicine;

•our ability to obtain and maintain regulatory approval of our product candidates;

•the implementation of our business model and strategic plans for our business, products, product candidates and technology;

•potential product launches, including the timing of launches;

•our ability to successfully commercialize our products, if approved;

•the pricing and reimbursement of our medicines, if approved;

•the build out of our manufacturing and commercial operations;

•estimates of our future expenses, revenues and capital requirements;

•our operation and funding requirements, including our forecast of the period of time through which our financial resources will be adequate to support our operations;

•the potential benefits of strategic collaboration agreements and our ability to enter into strategic collaborations or other agreements with collaborators with development, regulatory and commercialization expertise;

•our financial performance;

•our tax provision and related tax liabilities;

•legal and regulatory developments in the United States and foreign countries;

•our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost; and

•developments relating to our competitors and our industry.

Forward-looking statements often contain words such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our operational or financial performance, and involve risks, uncertainties, and other factors that may cause our actual results to differ materially from any future results expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section entitled “Risk Factors” and elsewhere in this Form 10-Q and under Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual results could differ materially from those expressed or implied by the forward-looking statements.

The forward-looking statements in this Form 10-Q represent our views as of the date of this Form 10-Q. We undertake no obligation to update any forward-looking statements, except as required by applicable securities law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Form 10-Q. However, any further disclosures made on related subjects in our subsequent reports filed with the Securities and Exchange Commission should be consulted.

TRADEMARKS

This Form 10-Q contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to may appear without the ® or ™ symbols, but such references are not intended to indicate that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our reference to other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

NOTE REGARDING COMPANY REFERENCES

Unless the context otherwise requires, the terms “Moderna,” the “Company,” “we,” “us” and “our” in this Form 10-Q refer to Moderna, Inc. and its consolidated subsidiaries.

ADDITIONAL INFORMATION

Our website, www.modernatx.com, including the Investor Relations section, www.investors.modernatx.com; and corporate blog www.modernatx.com/moderna-blog, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.twitter.com/moderna_tx (@moderna_tx); LinkedIn, www.linkedin.com/company/modernatx; Instagram (@moderna_tx); and Threads (@moderna_tx) contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. Information contained on our website, corporate blog and social media channels shall not be deemed incorporated into, or be a part of, this Form 10-Q.

Table of Contents


PART I.		Page
Item 1.	Financial Statements (Unaudited)	5
	Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023	5
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023	6
	Condensed Consolidated Statements of Comprehensive Income (Loss) for the three months ended March 31, 2024 and 2023	7
	Condensed Consolidated Statements of Stockholders' Equity for the three months ended March 31, 2024 and 2023	8
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023	9
	Notes to Condensed Consolidated Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	33
Item 4.	Controls and Procedures	33
PART II.
Item 1.	Legal Proceedings	34
Item 1A.	Risk Factors	34
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34

Item 6.	Exhibits	35
SIGNATURES		36

Table of Contents

Item 1. Financial Statements

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in millions, except per share data)


	March 31,		December 31,
	2024		2023
Assets
Current assets:
Cash and cash equivalents	$	2,051	$	2,907
Investments	6,472		5,697
Accounts receivable, net	137		892
Inventory	295		202
Prepaid expenses and other current assets	645		627
Total current assets	9,600		10,325
Investments, non-current	3,638		4,677
Property, plant and equipment, net	2,063		1,945
Right-of-use assets, operating leases	697		713

Deferred tax assets	81		81
Other non-current assets	650		685
Total assets	$	16,729	$	18,426
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	183	$	520
Accrued liabilities	1,396		1,798
Deferred revenue	559		568
Income taxes payable	52		63
Other current liabilities	190		66
Total current liabilities	2,380		3,015
Deferred revenue, non-current	58		83
Operating lease liabilities, non-current	637		643
Financing lease liabilities, non-current	575		575
Other non-current liabilities	262		256
Total liabilities	3,912		4,572
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, par value $0.0001; 162 shares authorized as of March 31, 2024 and December 31, 2023; no shares issued or outstanding at March 31, 2024 and December 31, 2023	—		—
Common stock, par value $0.0001; 1,600 shares authorized as of March 31, 2024 and December 31, 2023; 383 and 382 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively	—		—
Additional paid-in capital	487		371
Accumulated other comprehensive loss	(101)		(123)
Retained earnings	12,431		13,606
Total stockholders’ equity	12,817		13,854
Total liabilities and stockholders’ equity	$	16,729	$	18,426

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in millions, except per share data)


	Three Months Ended March 31,
		2024		2023
Revenue:
Net product sales		$	167	$	1,828
Other revenue		—		34


Total revenue		167		1,862
Operating expenses:
Cost of sales		96		792
Research and development		1,063		1,131
Selling, general and administrative		274		305
Total operating expenses		1,433		2,228
Loss from operations		(1,266)		(366)
Interest income		120		109
Other expense, net		(19)		(48)
Loss before income taxes		(1,165)		(305)
Provision for (benefit from) income taxes		10		(384)
Net (loss) income		$	(1,175)	$	79

(Loss) earnings per share:
Basic		$	(3.07)	$	0.20
Diluted		$	(3.07)	$	0.19

Weighted average common shares used in calculation of (loss) earnings per share:
Basic		382		386
Diluted		382		405

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited, in millions)


	Three Months Ended March 31,
		2024		2023
Net (loss) income		$	(1,175)	$	79
Other comprehensive (loss) income, net of tax:
Available-for-sale securities:
Unrealized gains on available-for-sale debt securities		20		79
Less: net realized losses on available-for-sale securities reclassified in net (loss) income		2		16
Net increase from available-for-sale debt securities		22		95
Cash flow hedges:
Unrealized gains on derivative instruments		—		—
Less: net realized losses on derivative instruments reclassified in net (loss) income		—		8
Net increase from derivatives designated as hedging instruments		—		8


Total other comprehensive income		22		103
Comprehensive (loss) income		$	(1,153)	$	182

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(Unaudited, in millions)


	Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Loss		Retained Earnings		Total Stockholders’ Equity
	Shares	Amount
Balance at December 31, 2023	382	$	—	$	371	$	(123)	$	13,606	$	13,854

Exercise of options to purchase common stock	1	—		15		—		—		15

Stock-based compensation	—	—		101		—		—		101
Other comprehensive income, net of tax	—	—		—		22		—		22

Net loss	—	—		—		—		(1,175)		(1,175)
Balance at March 31, 2024	383	$	—	$	487	$	(101)	$	12,431	$	12,817


	Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Loss		Retained Earnings		Total Stockholders’ Equity
	Shares	Amount
Balance at December 31, 2022	385	$	—	$	1,173	$	(370)	$	18,320	$	19,123

Vesting of restricted common stock	1	—		—		—		—		—
Exercise of options to purchase common stock	2	—		9		—		—		9

Stock-based compensation	—	—		75		—		—		75
Other comprehensive income, net of tax	—	—		—		103		—		103
Repurchase of common stock	(4)	—		(526)		—		—		(526)
Net income	—	—		—		—		79		79
Balance at March 31, 2023	384	$	—	$	731	$	(267)	$	18,399	$	18,863

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in millions)


			Three Months Ended March 31

SEC Form 10-Q filed by Moderna Inc.